Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations

What Was Tested

The trial (phase 1) is built around MariTide (Maridebart Cafraglutide).

It had two arms (groups): Maridebart Cafraglutide SC Presentation 1 (experimental) and Maridebart Cafraglutide SC Presentation 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 348 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, of any race, between 18 and 60 years of age, inclusive. Body mass index between ≥25.0 and \<40.0 kg/m\^2.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: history or evidence of endocrine disorder (eg, cushing's syndrome) that can cause obesity; malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this MariTide (Maridebart Cafraglutide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The MariTide (Maridebart Cafraglutide) group and the comparison group ran side by side rather than switching.

Everyone knew when MariTide (Maridebart Cafraglutide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-10-10 with completion listed for 2026-05-28.

It ran at 4 sites in United States (4).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide (time frame: Up to Day 120). Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide (time frame: Up to Day 120). Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide (time frame: Up to Day 120).

It also tracked 3 secondary outcomes, for example Number of Participants with Treatment-emergent Adverse Events, Number of Participants with Serious Adverse Events and Number of Participants with Anti-maridebart Cafraglutide Antibody Formation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 348 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.